Mulberry Leaf Extract and Blood Glucose Control in Diabetics

Craig, Nancy, M.D.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

Study type: Interventional

Identifiers

NCT01305434

MLE-DM2

Details and patient eligibility

About

Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries. Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by measuring blood glucose two hours after eating a meal and taking a capsule containing either mulberry leaf extract or a placebo.

Full description

Patients will participate in a double blind randomized cross over trial for 6 weeks. Four 2 weeks, half of the type 2 diabetic patients will receive mulberry leaf capsules three times per day with meals (made from Mulberry Zuccarin tablets - New Nordic, 400 mg of mulberry leaf extract per tablet) and half will receive placebo capsules. Following a one week wash out period, the treatments administered to each group will be reversed for the next 2 weeks, and data will continue to be gathered for a final wash out week. Patients will keep a diary of food, exercise, and fasting glucose each morning as well as at least one 2 hour pc glucose each day. Weight, hemoglobin A1C, liver function tests, and renal function tests will be done at baseline and at the end of the 6 weeks. As well, blood pressure will be monitored when the 2 weekly batches of medication are distributed, and at the end of the 6 weeks.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• baseline hemoglobin A1C greater than or equal to 7.5 or fasting glucose greater than 7 (SI units)

Exclusion criteria

• on insulin
• history of hepatic or renal disease
• pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Placebo then mulberry leaf

Other group

Description:

These patients receive placebo for two weeks, then 1 week washout, then two weeks of mulberry leaf extract.

Treatment:

Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose

Mulberry leaf then placebo

Other group

Description:

These patients receive mulberry leaf extract for two weeks, then 1 week washout, then two weeks of placebo.

Treatment:

Dietary Supplement: Mulberry leaf extract effect on post prandial blood glucose